RXC007 for Idiopathic Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

+38 other locations

Toby Michael Maher - Keck Medicine of USC

Overseen byPhilip Molyneaux, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Redx Pharma Ltd

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests RXC007, a new drug, for safety and side effects in patients with Idiopathic Pulmonary Fibrosis (IPF). Researchers will measure the drug levels in the blood and its impact on disease markers.

Eligibility Criteria

This trial is for adults aged 40-80 with Idiopathic Pulmonary Fibrosis (IPF) diagnosed within the last 5 years, having stable lung function and not on certain IPF treatments. Participants can be on nintedanib or pirfenidone if doses have been stable for at least a month. Exclusions include severe other diseases, recent infections, continuous oxygen need over 15 hours/day, and specific contra-indications to bronchoscopy.

Inclusion Criteria

I stopped taking nintedanib or pirfenidone for my IPF more than 4 weeks ago.

I have been on a stable dose of nintedanib or pirfenidone for my IPF for at least 4 weeks.

Your lung function is at least 50% of what's expected for someone your age and gender, and it hasn't gotten significantly worse since your last check-up.

See 5 more

Exclusion Criteria

I am being treated for IPF with medications not specifically approved for it.

I do not have conditions like severe lung or heart issues that make bronchoscopy unsafe for me.

I have not had a lung infection needing antibiotics in the last 4 weeks.

See 7 more

Treatment Details

Interventions

RXC007 (Other)

Trial OverviewThe study tests RXC007's safety and effects over 12 weeks in people with IPF, alone or alongside existing treatments like nintedanib or pirfenidone. It aims to understand how the body processes RXC007 and its impact on IPF symptoms compared to a placebo.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Expansion CohortExperimental Treatment2 Interventions

12:4 (RXC007 : Placebo) Dose level 3: 12 weeks (84 days) dosing

Group II: Cohort 2Experimental Treatment2 Interventions

12:4 (RXC007 : Placebo) Dose level 2: 12 weeks (84 days) dosing

Group III: Cohort 1Experimental Treatment2 Interventions

12:4 (RXC007 : Placebo) Dose level 1: 12 weeks (84 days) dosing